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A global research consulting group providing 360° support & services across all facets of clinical outcomes research.
Senior Medical Coder
Location
United States
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Senior Medical Coder
Clinical Outcomes Solutions
• Perform complex medical coding for adverse events, medical history, procedures, and concomitant medications using MedDRA and WHODrug dictionaries. • Review and validate coding performed by other coders to ensure consistency and accuracy. • Identify ambiguous or unclear terms and query clinical sites for clarification. • Maintain coding conventions and ensure alignment with study-specific and sponsor requirements. • Conduct ongoing coding checks during data cleaning cycles and prior to database lock. • Participate in the resolution of coding discrepancies, queries, and coding-related data issues. • Review safety data for coding accuracy in collaboration with medical monitors and safety teams. • Assist in the preparation of coding-related metrics, reports, and quality documentation. • Participate in vendor oversight activities when coding tasks are outsourced. • Stay current with updates to MedDRA and WHODrug dictionaries and communicate relevant changes to project teams. • Work closely with clinical data management to ensure proper term collection and standardization. • Partner with safety teams to support expedited reporting, signal detection, and regulatory submissions. • Support biostatistics and medical writing with queries related to coded terms for analyses and study reports.
Job Requirements
- Proficient in Medidata RAVE and Coder.
- Strong working knowledge of MedDRA and WHODrug dictionaries, including version control and update management.
- Bachelor's degree in life sciences, nursing, pharmacy, public health, or equivalent healthcare background; advanced degree preferred.
- 2 years of medical coding experience in clinical research, ideally within CRO, pharmaceutical, or biotech environments.
- Experience supporting multiple therapeutic areas; oncology, rare disease, or immunology experience preferred but not required.
- Excellent understanding of ICH-GCP, FDA, EMA, and other global regulatory guidelines.
- Strong attention to detail, analytical problem-solving, and ability to manage multiple projects simultaneously.
- Effective communication skills and experience collaborating in matrixed research environments.
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